Telormedix’s Vesimune completes Phase II trial for CIS of the bladder

The open-label trial involved 12 CIS patients recruited from sites in the US to examine the efficacy of Vesimune over six doses.

The trial population included both BCG pre-treated and naive patients with each patient received six weekly instillations of Vesimune into the bladder.

Of the 12 patients, ten were evaluable with four showing a response, and three out of the four were complete responders and therefore reached the clinical endpoint of complete remission after only one cycle of therapy.

The company said that only mild and moderate side effects were observed in the trial, mostly associated directly to the bladder and comparable to other commonly used intravesical agents.

Active ingredient in Vesimune is a known immuno-modulatory molecule with a favourable safety profile and a demonstrated clinical efficacy in oncological and viral diseases.